Active surveillance or immediate treatment? The question that many men with prostate cancer and their clinicians struggle with continues to be a focus in the updated NCCN Guidelines for Prostate Cancer. James L. Mohler, MD, of Roswell Park Comprehensive Cancer Center, chair of the NCCN Guidelines Panel for Prostate Cancer, discussed more rigorous monitoring of men undergoing active surveillance and new treatment options for advanced prostate cancer in the recently updated NCCN Guidelines during a presentation at the NCCN 16th Annual Conference.

Active surveillance, also referred to as watchful waiting, is a viable option for many men with low-risk prostate cancer, although the concept continues to cause distress and confusion for many men — especially when they read about the controversies associated with the use of prostate-specific antigen (PSA) for the early detection of prostate cancer, noted Dr. Mohler, who is Chair of the Department of Urology and Associate Director and Senior Vice President for Translational Research at Roswell Park.

“The NCCN Guidelines Panel remains concerned about over-diagnosis and over-treatment of prostate cancer, as growing evidence suggests that over-treatment of prostate cancer commits too many men to side effects that outweigh a very small risk of prostate cancer death,” Dr. Mohler said.

The NCCN Guidelines for Early Detection of Prostate Cancer recommend that at age 40, high-risk men begin annual PSA and prostate exams. “All other men at age 40 should be offered a baseline PSA and prostate exams and, if their PSA is 1.0 ng/mL or greater, they should receive annual follow-ups,” Dr. Mohler said. “If their PSA is less than 1.0, the NCCN Guidelines recommend that these men be early detected again at age 45,” said Dr. Mohler.

In 2010, the NCCN Guidelines established a new “very low risk” category. In the updated 2011 NCCN Guidelines, active surveillance monitoring was made more rigorous for men in the very-low-risk category. For those with a life expectancy of less than 20 years, PSA must be measured at least every 6 months, prostate exam must be performed at least every 12 months, and repeat prostate biopsies should be considered as often as every 12 months.

Another significant update to the NCCN Guidelines was the inclusion of sipuleucel-T (Provenge, made by Dendreon Corp.) as an immunotherapy option for asymptomatic or minimally symptomatic castration-recurrent metastatic prostate cancer. The updated NCCN Guidelines also include cabazitaxel (Jevtana, made by Sanofi-Aventis) as a new second-line option for men with castration-recurrent metastatic prostate cancer.

“The addition of both of these therapies into the NCCN Guidelines represents a significant advancement in the care of men with advanced prostate cancer,” said Dr. Mohler.

Also, denosumab (Xgeva, made by Amgen) has been added to the NCCN Guidelines as an alternative to zoledronic acid (Zometa, made by Novartis Oncology) for the prevention of skeletal-related events.

Dr. Mohler said the choice of which agent to use should depend upon several variables, including under-lying co-morbidities and whether the patient has been treated with zoledronic acid previously.

The National Comprehensive Cancer Network (NCCN) is a not-for-profit alliance of 21 of the world’s leading cancer centers, including Roswell Park Comprehensive Cancer Center, dedicated to improving the quality and effectiveness of care provided to patients with cancer.